What happened
Par Health announced a voluntary nationwide recall to the hospital level of two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) after particulate matter identified as cellulose was found. The affected lots are 86930, expiring February 2028, and 88623, expiring April 2028; they were distributed to wholesalers nationwide between July 8, 2025, and May 11, 2026. Par said use could cause life-threatening vascular consequences, although it had received no related adverse-event reports. Wholesalers and hospital pharmacies were instructed to stop use and distribution immediately, notify downstream accounts, and return inventory through Inmar. FDA posted the company announcement and noted that posting does not constitute endorsement.
Why it matters
From a GMP and pharmaceutical manufacturing perspective, cellulose particulate in an injectable product makes particulate and contamination controls directly relevant because the company associates administration with serious vascular harm. The lot-specific stop-use, downstream notification, and return instructions also underscore the role of batch traceability and inventory control in recall execution. The announcement does not state the source of the cellulose or describe an investigation, root cause, or corrective actions.
Key topics: Cellulose particulate matter in Brevital Sodium, Recall of lots 86930 and 88623, Hospital-level stop-use and product returns